PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB

May 11, 2026 updated by: Axonics, Inc.

Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System Model 5101 (R20) for the Indication of Overactive Bladder (OAB)

Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This post-market clinical follow-up (PMCF) is conducted to assess the continued safety, device performance, and clinical benefit of the rechargeable Axonics SNM System INS Model 5101 also referred to as R20.

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • London, United Kingdom, W1G 8PH
        • Recruiting
        • University College London Hospital
        • Principal Investigator:
          • Mahreen Pakzad, MD
        • Contact:
          • Nadia Malabi
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD96RJ
        • Recruiting
        • Bradford Royal Infirmary
        • Contact:
          • Karen Regan
        • Contact:
          • Stephen Cox
        • Principal Investigator:
          • Elizabeth Kidger, MD
      • Wakefield, West Yorkshire, United Kingdom, WF1 4DG
        • Recruiting
        • Pinderfields Hospital
        • Contact:
          • Toyin Familade
        • Principal Investigator:
          • Ased Ali, MD
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Principal Investigator:
          • Kimberly Kenton, MD
        • Contact:
          • Rowena Shi
    • Missouri
      • Columbia, Missouri, United States, 65211
        • Recruiting
        • University of Missouri
        • Contact:
          • Hailey Schlaffer
        • Principal Investigator:
          • Raymond Foster, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 18 years or older
  2. Primary indication of OAB (urinary urgency incontinence (UUI) / urinary frequency (UF) who are not candidates for, or who have failed conservative treatment
  3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments

Exclusion Criteria:

  1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis)
  2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements
  3. Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)
  4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone
  5. A female who is breastfeeding
  6. A female with a positive urine pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Overactive Bladder
Participants with the Axonics SNM System Model 5101 and followed up regarding their overactive bladder symptoms.
Device: Axonics SNM System INS Model 5101 (R20)
Participants treated with the rechargeable Axonics SNM System Model 5101 also referred to as R20. Commercial devices used in this study are within their intended use as described in each geography's approved instructions for use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)
Time Frame: 3 months
To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder Qualify of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
3 months
Adverse event reporting (Safety)
Time Frame: 3 months
Device related, procedure-related and all serious adverse events
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Performance/Effectiveness - Improvement in Qualify of Life scoring (OAB)
Time Frame: 12 months
To demonstrate an improvement in Overactive Bladder Quality of Life using the International Consultation of Incontinence Questionnaire Overactive Bladder Qualify of Life (ICIQ-OABqol): questions in each subscale are scored by a summed range of 0 to 100, with a higher score indicating better quality of life. Overall score ≥ 10 points from baseline to follow-up is indicative of a clinically meaningful improvement.
12 months
Performance/Effectiveness - Improvement in Qualify of Life scoring (FI)
Time Frame: 12 months
Cleveland Clinic Florida - Fecal Incontinence Score (CCF-FIS): scores range from 0 for full continence to 20 for complete incontinence. A higher score is indicative of the severity of fecal incontinence. Assessed if participant had a score of ≥6 at baseline.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axonics, Inc.

Investigators

  • Principal Investigator: Mahreen Pakzad, MD, University College London Hospitals
  • Study Director: Gita Ghadimi, OD, Boston Scientific Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

October 1, 2031

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

January 23, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105-0104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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